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WATCHMAN Device for Stroke Prevention in Atrial Fibrillation (ASAP-TOO Trial)

N/A

Waitlist Available

Led By Vivek Reddy, MD

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial

The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

ASAP-TOO Trial Summary

This trial is testing a new method to reduce the risk of stroke for people with atrial fibrillation who can't take blood thinners.

Who is the study for?

This trial is for adults with non-valvular atrial fibrillation who can't take blood thinners. They must be able to take aspirin and clopidogrel after getting the WATCHMAN device implanted, willing to consent, and commit to follow-up visits. Excluded are those needing certain surgeries soon, with severe heart issues or bleeding disorders, pregnant women, or those in conflicting studies.Check my eligibility

What is being tested?

The study tests the WATCHMAN Left Atrial Appendage Closure Device's safety and effectiveness in reducing stroke risk without standard blood thinners. Participants will either receive this implant plus a special medication regimen or no therapy as control.See study design

What are the potential side effects?

Potential side effects from the WATCHMAN device may include discomfort at the implant site, bleeding complications, possible allergic reactions to device materials or medications post-implant like aspirin and clopidogrel.

ASAP-TOO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and am willing to sign the consent form.

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I have a type of irregular heartbeat not caused by a heart valve issue.

ASAP-TOO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary 7-Day Device/Procedural Safety Endpoint

Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism.

Secondary outcome measures

Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death

Hemorrhage

ASAP-TOO Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: WATCHMAN (Device)Experimental Treatment1 Intervention

WATCHMAN LAAC Device implant including modified post-implant drug regimen.

Group II: ControlActive Control1 Intervention

Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor

718 Previous Clinical Trials

932,467 Total Patients Enrolled

10 Trials studying Stroke

9,552 Patients Enrolled for Stroke

Vivek Reddy, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

33 Previous Clinical Trials

10,815 Total Patients Enrolled

2 Trials studying Stroke

2,898 Patients Enrolled for Stroke

Maurice Buchbinder, MDPrincipal InvestigatorStanford University

3 Previous Clinical Trials

915 Total Patients Enrolled

Media Library

WATCHMAN LAAC Device Implant (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02928497 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for participants in this research project?

"According to information found on clinicaltrials.gov, the recruitment window for this medical trial has already passed - it was first published on February 6th 2017 and last modified November 29th 2022. However, there are still 1043 other medical trials actively recruiting patients at present."

Answered by AI

How widely dispersed is this clinical trial's implementation within the United States?

"Nair Research, LLC. in Jonesboro, North Mississippi Medical Center in Tupelo, Billings Clinic in Billings are just some of the 75 operating medical centres offering this clinical trial."

Answered by AI